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RegisterDeconvolution sample size and exponential terms [Power / Sample Size]
Dear Mittyri!
Is the aim here to develop an IVIVC or develop a new MR formulation of drug that is already authorized in a formulation with a different release rate? I believe we are focusing on (dosing regiment)IR vs MR. So at least CV for AUC depending on matrix would be taken into consideration.
It means that same model needs to be applied to all individual to derive individual exponential terms to evaluated individual deconvoluted profile.
Regards,
Divyen
❝ As for other studies, just CV is not enough. What are the regulatory limits then and for what metric? That phrase in MR GL seems like just exploratory analysis with descriptive statistic, since there are no predictions and no checking against set of MR formulations as we do in IVIVC
Is the aim here to develop an IVIVC or develop a new MR formulation of drug that is already authorized in a formulation with a different release rate? I believe we are focusing on (dosing regiment)IR vs MR. So at least CV for AUC depending on matrix would be taken into consideration.
❝ Does it mean that exponential terms should be derived from individual models of subjects after dosing by IR product?
It means that same model needs to be applied to all individual to derive individual exponential terms to evaluated individual deconvoluted profile.
Regards,
Divyen
Complete thread:
- Deconvolution sample size and design issues mittyri 2023-02-09 14:40
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Deconvolution sample size and design issues dshah 2023-02-09 16:20
- Deconvolution sample size and exponential terms mittyri 2023-02-09 22:08
- Deconvolution sample size and exponential termsdshah 2023-02-10 09:34
- Deconvolution sample size and exponential terms mittyri 2023-02-09 22:08
- Deconvolution sample size and design issues dshah 2023-02-09 16:20
Ing. Helmut Schütz